Quality Assurances SOPs List

Quality Assurances SOPs List

SNo.SOP Title
01SOP on validation master plan
02SOP on Function of quality assurance department
03SOP on periodic physical observation of control sample
04SOP on job responsibility of personnel working in quality assurance.
05SOP on in-process sampling and analysis of oral drug products.
06SOP on in-process checks during dry powder injection manufacturing & packing
07SOP on dossier numbering
08SOP on post packing check of finished product before transfer to warehouse
09SOP on allocation of Bar Code
10SOP on document management system in quality assurance department
11SOP on preparation of Site Master File.
12SOP on preparation, review, approval, distribution, control, & revision of sop.
13SOP on document numbering and data control.
14SOP on equipment / instrument numbering
15SOP on change control procedure
16SOP on handling of deviations
17SOP on training to employee
18SOP on document entries
19SOP on disinfectant usage policy
20SOP on handling of non- conformance report
21SOP on issue and control of formats.
22SOP on scrap handling policy.
23SOP on destruction policy of drug products & its components.
24SOP on internal quality audit   (self inspection)
25SOP on job description /responsibilities to all the employees
26SOP on specimen signature to all employees.
27SOP on Product Recall
28SOP on Annual Product Quality  Review
29SOP on operation of Xerox cum scan machine
30SOP on intimating all departments for reviewing of SOP.
31SOP on department room numbering for the formulation plant
32SOP on AHU numbering
33SOP on AHU grill numbering.
34SOP on corrective and preventive action (CAPA)
35SOP on Transfer of Technology for Manufacturing process
36SOP on rectification of errors
37SOP on Transfer of Technology for Analytical Method
38SOP on batch numbering of drug products.
39SOP on review, audit and storage of batch records and testing records.
40SOP on release of finished product.
41SOP on monitoring of temperature, RH and pressure differential.
42SOP on line clearance.
43SOP on operation of disintegrator tester.
44SOP on cleaning of disintegration test apparatus.
45SOP on calibration of disintegration test apparatus.
46SOP on operation of friability test apparatus.
47SOP on cleaning of friability test apparatus.
48SOP on calibration of friability test apparatus
49SOP on operation of leak test apparatus
50SOP on cleaning of leak test apparatus.
51SOP on operation of analytical balance
52SOP on cleaning of analytical balance
53SOP on operation of hardness tester.
54SOP on cleaning of hardness tester.
55SOP on operation of vernier caliper.
56SOP on cleaning of vernier caliper.
57SOP on operation of moisture analyzer
58SOP on cleaning of moisture analyzer
59SOP on Vendor approval for raw material
60SOP on Raw Material code Numbering System and its applicability
61SOP on Handling of market Complaints
62SOP on Handling, Investigation and Reporting  of out of Specification (OOS) Result
63SOP on Design Qualification Guideline for minimizing the Risk of Product Cross Contamination of factory equipment and process.
64SOP on batch numbering system for trial batches.
65SOP on writing & approval of validation protocol & reports.
66SOP on review of batch processing and control record.
67SOP on rounding off the quantity of ingredients in the formula.
68SOP on maintaining equipment/instrument log book.
69SOP on approval of art work print proof and shade card of printed packaging material.
70SOP on equipment operation, cleaning & maintenance of log book
71SOP on in Process labelling and its format numbering
72SOP sampling of bulk & finished product, rinse, swab test for testing
73SOP on Preparation, review, approval, distribution, control and revision of Specifications, Standard test procedures and General test procedure.
74SOP on preparation, control, issuance and revision of batch manufacturing and batch packing records.
75SOP on reprocessing & rework due to non-conformance of the product
76SOP on withdrawal, storage, observation & destruction of control / retention sample.
77SOP on packing material code numbering system and its applicability
78SOP on Maximum Retail Price list for finished products
79SOP on standard Packing Material Specification
80SOP on vendor approval for Packaging Material
81SOP on calibration of analytical balance
82SOP on control of labels, tags, log books and registers
83SOP on Product failure Investigation
84SOP on procedure for monitoring of compresses air.
85SOP on code numbering system of utility and miscellaneous products.
86SOP on verification of sampling dies
87SOP on initiation and reviewing of Manufacturing Master formula (MFC )
88SOP on sampling of rinse and swab samples after equipment cleaning
89SOP on Sieve Numbering
90SOP on Screen Numbering

About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

Check Also

VIRTUAL INSPECTION

VIRTUAL INSPECTION PURPOSE: To lay down the procedure for establishing a comprehensive system of virtual …